Wholesale CE Certification In Vitro Diagnostic Test Manufacturers Exporters – 2019-nCoV Ag Test (Latex Chromatography Assay) / Self-Test / Anterior Nasal Swab – INNOVITA Manufacturer and Supplier

CE Certification In Vitro Diagnostic Test Manufacturers Exporters – 2019-nCoV Ag Test (Latex Chromatography Assay) / Self-Test / Anterior Nasal Swab – INNOVITA

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Our enterprise since its inception, often regards solution excellent as enterprise life, continually strengthen output technology, enhance product high quality and continually strengthen organization total high-quality administration, in strict accordance using the national standard ISO 9001:2000 for COX B, Medical Diagnostic Kits, Rapid test, We focus on to make excellent quality products to supply service for our clients to establish long-term win-win relationship.

CE Certification In Vitro Diagnostic Test Manufacturers Exporters – 2019-nCoV Ag Test (Latex Chromatography Assay) / Self-Test / Anterior Nasal Swab – INNOVITA Detail:

Product Detail:

Innovita® 2019-nCoV Ag Test is intended for the direct and qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in anterior nasal swab that is self-collected by an individual aged 18 years or older or is collected by an adult from young individuals. It only recognizes the N protein and cannot detect the S protein or its mutation site.
The kit is intended for layperson as self-testing at home or at work (in offices, for sports events, airports, schools, etc.)

What is self-test:

A self-test is a test that you can carry out yourself at home, to reassure yourself that you are not infected before going to school or work. Self-test is recommended regardless whether you have symptoms or not to quickly check whether you need immediate attention. If your self-test produces a positive result, you probably have been infected with coronavirus. Please contact test center and doctor to arrange for a confirmation PCR test and follow the local COVID-19 measures.

Composition:

Specification	Test cassette	Extraction diluent	Dropper tip	Swab	Garbage bags	IFU
1 test/box	1	1	1	1	1	1
2 tests/box	2	2	2	2	2	1
5 tests/box	5	5	5	5	5	1

Test Procedure:

1.Specimen Collection


1. Take out the swab from the package without touching the padding.	2. Carefully insert the swab 1.5cm into the nostril until slight resistance is noticeable.	3. Using moderate pressure, turn the swab 4 – 6 times in a circular motion for at least 15 seconds.	4. Repeat the sampling with the same swab in the other nostril.

2.Specimen Handling


1. Peel the cover.	2. Insert the swab into the tube. The swab tip should be completely immersed in the diluent, and then stir 10-15 times to ensure that an adequate specimen is collected.	3. Squeeze the tube.	4. Remove the swab and then cover the lid and the extraction solution can be used as the test specimen.

3.Test Procedure

	wait 15~30 minutes
1. Apply 3 drops of the test specimen into the specimen well.	2. Read results between 15~30 minutes. Do not read the result after 30 minutes.

Results Interpretation:

Anterior Nasal Swab (1)

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Our corporation puts emphasis about the administration, the introduction of talented staff, plus the construction of team building, attempting hard to improve the quality and liability consciousness of team members. Our organization successfully attained IS9001 Certification and European CE Certification of CE Certification In Vitro Diagnostic Test Manufacturers Exporters – 2019-nCoV Ag Test (Latex Chromatography Assay) / Self-Test / Anterior Nasal Swab – INNOVITA , The product will supply to all over the world, such as: Kuwait, Zimbabwe, Dubai, Our company abides by the management idea of "keep innovation, pursue excellence". On the basis of assuring the advantages of existing products, we continuously strengthen and extend product development. Our company insists on innovation to promote the sustainable development of enterprise, and make us become the domestic high-quality suppliers.

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